Client

• Global, clinical-stage biopharmaceutical company developing innovative immune-targeted cancer therapies

Challenge

• Provide medical writing assistance for a manuscript reporting results from a Phase 3 randomised controlled trial in The Lancet Respiratory Medicine.
• Interpret complex and extensive data from multiple international study sites.
• Provide strategic guidance to the client regarding journal expectations, Good Publication Practice (GPP) guidelines, and reporting requirements for clinical trials.
• Adhere to stringent journal requirements; The Lancet Respiratory Medicine has strict guidelines for manuscript structure, content, and formatting, necessitating a thorough understanding and adherence to these requirements.
• Balance manuscript detail and clarity. Ensuring the manuscript was sufficiently detailed while remaining concise and accessible.
• Focus on communicating the key messages. A unique position of a medical writer is that we can be objective in our approach to reporting the outcomes, while avoiding the temptation to include additional data which, although interesting, may detract from the key messages of the paper.
• Coordination with multiple stakeholders, including ~50 international authors, statisticians and the client.

 Approach

• Planning, coordination, and communication:
  • Initial meeting with the client to understand the key objectives and timelines.
  • Created a project timeline and set deadlines to ensure timely completion.
  • Set up regular calls with the client to ensure timely discussion.
• Data organisation and analysis:
  • Worked with the statistician to interpret the study data, ensuring accuracy and consistency in the presentation of results.
  • Developed appropriate tables and figures to illustrate the main outcomes.
• Drafting the manuscript:
  • Emphasised the clinical significance of the findings in a balanced manner, highlighting the potential impact on patients.
  • Utilised clear and concise language to effectively convey complex information, making the manuscript accessible to a wide medical audience.
• Adhering to journal guidelines and CONSORT requirements:
  • Reviewed The Lancet Respiratory Medicine’s author instructions and CONSORT guidelines in detail, ensuring all aspects of the manuscript, including format, style, and structure, met the required standards.
  • Utilised reference management software (EndNote) to organise citations and ensure accurate formatting.
• Collaborative review and finalisation:
  • Facilitated multiple rounds of review with the authors, addressing comments and refining the manuscript to enhance clarity and coherence.
  • Ensured all ethical and conflict of interest statements were accurately reported, in compliance with journal requirements.
• Submission and follow-up:
  • Submitted the manuscript through The Lancet Respiratory Medicine’s online submission system, ensuring all supplementary materials and required documents were included.
  • Prepared responses to multiple rounds of peer reviewer and editor comments, promptly coordinating with the client, authors, and statistician to address requests for additional data or provision of scientific rationale.
  • Meticulously revised the manuscript, incorporating feedback from co-authors and ensuring consistency in terminology and data presentation.
  • Once the journal proofs were received, a thorough comparison with the submitted manuscript was conducted to ensure the accuracy of tables, figures and text and confirm any journal editorial changes did not impact the data or intended messages.
  • Responded to final editorial queries, liaising with the client and lead author, within a tight deadline.

Result

• Diligent collaboration, meticulous organisation and clear communication resulted in the successful submission and acceptance of the manuscript by The Lancet Respiratory Medicine.
• The published Phase 3 study provides robust evidence supporting the efficacy and safety of a potential new treatment for very ill patients who have limited treatment options.
• This experience demonstrates the success of thorough planning, clear communication, and collaborative teamwork.
• By effectively interpreting complex data and adhering to stringent guidelines, we produced a high-quality publication that met the expectations of a prestigious journal.

Thank you so much for your enormous efforts and great job! You are so organized!

Thank you, Claire for your brilliance.

So appreciative of your diligence and great work product!

Claire really did such a great job to get this manuscript proof done and submitted.